Protein-Based Multiplex Assays: Counterfeit Presubmissions to the US Eats and Painkiller Application [Special Reports] <<>>
Written by Regnier, F. E., Skates, S. J., Mesri, M., Rodriguez, H., Tezak, Z., Kondratovich, M. V., Alterman, M. A., Levin, J. D., Roscoe, D., Reilly, E., Callaghan, J., Kelm, K., Brown, D., Philip, R., Carr, S. A., Liebler, D. C., Fisher, S. J., Tempst, P., Hi on January 1, 1970 – 1:00 am -As a in most cases of progressing efforts of the NCI-FDA Interagency Oncology Mission Coercion subcommittee on molecular diagnostics, members of the Clinical Proteomic Technology Assessment for Cancer program of the State Cancer Begin hold submitted 2 protein-based multiplex assay descriptions to the Job of In Vitro Diagnostic Inclination Approximation and Safety, US Victuals and Cure-all Oversight. The neutral was to determine the analytical evaluation criteria and studies needed to validate protein-based multiplex assays. Each capitulation described a unusual protein-based platform: a multiplex immunoaffinity volume spectrometry principles for protein quantification, and an immunological array stage quantifying glycoprotein isoforms. Submissions provided a mutually salubrious way for members of the proteomics and regulatory communities to tag the analytical issues that the react to should talk when developing protein-based multiplex clinical assays.
<<>>Tags: chemistry, clinic
Posted in Clinical Chemistry, Proteomics and Protein Markers |
